A multi-center, double-blind, randomized, active reference, parallel group study to evaluate the efficacy, safety and tolerability of a 10-day twice daily oral administration of 3 doses of ACT-179811 in subjects with Clostridium difficile infection (CDI)
- Conditions
- Clostridium difficile infectionMedDRA version: 12.1Level: LLTClassification code 10054236Term: Clostridium difficile infection
- Registration Number
- EUCTR2010-020941-29-SE
- Lead Sponsor
- Actelion Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 92
Inclusion Criteria
Male or female.
At least 18 years old.
Subject with a diagnosis of CDI: first occurrence or first recurrence.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Concurrent life threatening condition.
Immuno-compromised subjects, concomittant immuno-suppresive treatment.
Concomitant antimicrobial treatment for CDI.
Concomitant treatment with another investigational drug.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of a 10-day twice daily (b.i.d.) oral administration of 3 doses of ACT-179811 on cure.;Secondary Objective: To evaluate the effect of ACT-179811 on disease recurrence and its safety and tolerability in subjects with CDI;Primary end point(s): Cure.
- Secondary Outcome Measures
Name Time Method